Probiotics in the Treatment of Iron Deficiency in Children With Restless Leg Syndrome

Completed · Phase 2 · Has a placebo group

Conditions studied: Iron Deficiency, Restless Leg Syndrome

In brief

A double-blind randomized controlled trial comparing iron plus vitamin C plus probiotic (lactobacillus plantarum 299) to iron plus vitamin C plus placebo in correcting the iron deficiency in children with Restless leg syndrome (RLS) and iron deficiency. One hundred children with diagnosis of RLS will be recruited over a two- year period.

Key facts

Study ID

NCT01617044

Run by

Children's Hospitals and Clinics of Minnesota

People needed

61

Starts

2012-05-01

Expected to finish

2015-11-01

Last updated by the study team

2016-01-20

Who can join

Age: 5 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ages 5-18 years
• RLS defined by NIH criteria -definite or probable (see appendix)
• Serum ferritin level less than 50 mcg/l
• CRP less than 10 mg/l

You may not qualify if…

• Immune compromised
• Milk intolerant/allergic
• Known allergy or intolerance to probiotics for iron
• History of hematochromatosis
• IV catheter or indwelling medical device
• Chronic gastroenteritis or malabsorption

Where it is running

• Children's Hospitals and Clinics of Minnesota — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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